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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077155 |
RATIONALE: Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cilengitide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors |
Estimated Enrollment: | 45 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study within 5.3-13 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No active brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent anticoagulation therapy that increases INR or aPTT above the normal range
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 |
Study Chair: | Samir D. Undevia, MD | University of Chicago |
Study ID Numbers: | CDR0000349535, UCCRC-12774A, NCI-6362 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077155 |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma |
stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma stage III grade 1 follicular lymphoma |
Sezary syndrome Hodgkin's disease Hodgkin lymphoma, adult Cutaneous T-cell lymphoma Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Lymphoma, large-cell Lymphoma, B-Cell Burkitt's lymphoma |
Leukemia Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy Lymphoblastic lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |